Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

There is no experience with or evidence of safety issues on the use of the propellant norflurane (HFA134a) during human pregnancy or lactation. However, studies on the effect of HFA134a on the reproductive function and embryofoetal development in animals revealed no clinically relevant adverse effects.

Pregnancy

There are no or limited amount of data from the use of Trimbow 100/6/12.5 in pregnant women.
Studies in animals have shown reproductive toxicity (see section 5.3). Glucocorticoids are known to cause effects in the early gestation phase, while beta2-sympathomimetics like formoterol have tocolytic effects.
Therefore, as a precautionary measure, it is preferable to avoid the use of Trimbow 100/6/12.5 during pregnancy and during labour.

Trimbow 100/6/12.5 should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the foetus. Infants and neonates born to mothers receiving substantial doses should be observed for adrenal suppression.

Breast-feeding

There are no relevant clinical data on the use of Trimbow 100/6/12.5 during breast-feeding in humans.
Glucocorticoids are excreted in human milk. It is reasonable to assume that beclometasone dipropionate and its metabolites are also excreted in human milk.
It is unknown whether formoterol or glycopyrronium (including their metabolites) are excreted in human milk but they have been detected in the milk of lactating animals. Anticholinergics like glycopyrronium could suppress lactation.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Trimbow 100/6/12.5 therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

No specific studies have been performed with Trimbow 100/6/12.5 with regard to the safety in human fertility. Animal studies have shown impairment of fertility (see section 5.3).